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Forest Laboratories, Inc. has announced that FETZIMA (levomilnacipran extended-release capsules) has been approved by the FDA for treatment of major depressive disorder (MDD).
MDD is a serious medical condition affecting almost 16 million adults in the United States each year. People with this type of depression often struggle to find effective treatment.
FDA-approval of FETZIMA offers a new option for people struggling with depression. Use is intended for adults exclusively.
FETZIMA is a serotonin and norepinephrine reuptake inhibitor (SNRI) marketed for the treatment of adult MDD. It is not approved for other uses.
In three placebo-controlled studies, statistically significant and clinically meaningful improvement in depressive symptoms was demonstrated across three different dosage strengths.
As with other antidepressants, there is an increased risk of suicidal thoughts and behavior, especially in children, adolescents and young adults. Therefore usage is not recommended for those age groups. There was no increase in suicidal thoughts for people over the age of 24.
FETZIMA is not a good drug for people with a hypersensitivity to levomilnacipran, milnacipran HCI or any excipient in the formulation. Starting FETZIMA in a patient who is being treated with MAOIs like linezolid or intravenous methylene blue is contraindicated because of an increased risk of serotonin syndrome. FETZIMA may also not be used by people who have uncontrolled narrow-angle glaucoma.
The most common adverse reactions for people in the study were nausea, constipation, hyperhidrosis, heart rate increased, erectile dysfunction, tachycardia, omitting and palpitations.
Now that FETZIMA has FDA-approval, you can talk to your doctor about whether this drug might be right for you. As with all antidepressant use, patients should be monitored for worsening of symptoms, suicidal thoughts and unusual changes in behavior.
Source: MedicalNewsToday, Forest Laboratories
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